Think about the last time you saw a demonstration of a new medical device. Were you guided through all the new and innovative features by an expert who was able to step in and assist with any questions or difficulties as you tried it for the first time?
Now think about the last time you found yourself interacting with a new-to-you medical device in a real-life, time-sensitive situation. Did you feel prepared and fully trained? Did you know exactly how to use it or did you have difficulty interacting with the medical device?
Sadly, there are many stories of medical devices that contribute to adverse events, which have resulted in harm to staff and patients. For example, there were five deaths and 68 injuries related to the incorrect programming of infusion pumps between 2007 and 2015 as reported in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. Most of these reported incidents involved cases where programming errors resulted in unintentional drug overdoses or underdoses being given to patients.
Adverse events involving medical devices aren’t just limited to the clinical setting either. Issues related to the service and repair of devices occur, too. For example, between 2007 and 2017, there were three deaths and 42 injuries related to device calibration errors reported in the MAUDE database.
Medical device design and the way that end users interact with medical devices should be an important consideration for hospitals today because devices that haven’t been designed, selected, and implemented with end users in mind can contribute to preventable adverse events.
One of the specialties that focus on understanding and preventing adverse events is human factors engineering. Human factors engineering is a discipline dedicated to identifying and addressing areas of mismatch between people, devices, technologies, and environments. When people use devices or work in environments that don’t support them, errors or near misses can occur. By designing, selecting, and implementing devices using human factors principles, we can consider the fit between system elements and understand how end users are likely to perform in the real world.
Recently, the FDA has helped to shine a spotlight on the importance of human factors engineering in the design and development of medical devices, with the release of published guidance and regulations to ensure vendors consider the fit between humans and devices during device design and development.
From a hospital perspective, this is good news, but it is just the tip of the iceberg. Because the needs of users in different hospitals and hospital settings can vary so greatly, it’s important for hospitals to consider the specific users and environments in which devices will be employed, in addition to hospital-level requirements, when procuring and implementing new medical devices. This careful consideration can be achieved through human factors-informed procurement.
Human factors-informed procurement is an approach to procurement that builds on traditional procurement processes and incorporates human factors methods and standards into the decision-making process. In this way, you can ensure the device supports end users in the intended context of use—in addition to selecting a product that meets technical specifications, clinical requirements, budgetary constraints, and comes from a reputable vendor that can provide training and support over time. This facilitates a good fit across the entire system, which includes your end users, devices, other interfacing technologies, environments of use, and the hospital or hospital system.
The first step in a human factors-informed procurement approach is to identify your stakeholders, including any and all end users. Next, identify the needs and wants of your stakeholders with respect to the new device. Include that information in your RFP, and evaluate the responses with that stakeholder feedback in mind. Once the field of potential devices has been narrowed, assess each potential device against technical specifications and budgetary constraints. Evaluate each potential device using human factors methods, such as heuristic analysis and usability testing.
Based on the results of all analyses, make a decision to move forward with the most appropriate device. Proceed with device and environment configuration—as well as training, education and support—informed by the results of heuristic and usability testing.
Taking a human factors-informed approach to procurement allows stakeholders, including end users, to have a say in this crucial process. This approach can also help with getting user buy-in, providing insight to the specific issues likely to occur in your context of use and allowing for implementation with the proper device and environment configuration, training and support plans in place. Further, adverse events due to device design issues are unlikely to occur, since most would have been identified during heuristic and usability testing. It’s at that stage that you have an opportunity to work with the vendor to solve any such issues prior to implementing the device in your institution.
For more information about human factors-informed procurement, see http://cedglobal.org/human-factors-for-health-technology-safety/
Melissa Kozak is a clinical engineer at the Techna Institute with University Health Network in Canada.